Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Medtech Dive, in “FDA Finalizes Speedier Medical Device Pathway Alternative to Breakthrough Status,” by Nick Paul Taylor.

Following is an excerpt:

FDA Tuesday published final guidance on its new Safer Technologies Program for Medical Devices (STeP) program, targeted at products with significant safety benefits in non-life-threatening or reasonably reversible conditions less serious than those eligible for the agency's Breakthrough Devices Program.

The guidance for its voluntary STeP program is intended to provide additional support to developers of devices that significantly improve on existing products but do not meet all the criteria for the Breakthrough Devices Program, while preserving the statutory standards for premarket approval, De Novo marketing authorization, and 510(k) clearance.

AdvaMed pushed back against elements of the draft STeP guidance in 2019. The final guidance features changes to sections criticized by the lobbying group, specifically in relation to what qualifies as a "significant" improvement to patient safety. …

Modeled after the FDA's Breakthrough Devices Program, the agency intends for STeP to similarly incorporate "interactive and timely communications, early engagement on Data Development Plans (DDPs), sprint discussions, and senior management engagement."

However, Bradley Merrill Thompson, attorney at Washington, D.C. law firm Epstein Becker Green, points out that FDA offers no assurance of a quicker review or accelerated time frames with STeP.

"It's all just a vague commitment to work with the sponsor and invest more agency time," Thompson said. "They talk about finding an efficient path, but they are legally required to pursue the least burdensome pathway for all medical devices. So, if they have figured out some clever, efficient way of going about the regulatory process for a device, they ought to be applying that regardless of whether a device is in this program."

Thompson contends that while offering incentives to medtechs to improve safety is a "laudable" goal, he believes the program will be difficult to administer precisely because it focuses on safety.

"In contrast to the Breakthrough Devices Program, where the issue is whether the device is intended for use in an important way or evidences a novel approach, safety is proved in the pudding.  And that improved safety may not reliably be assessed until well into the evidence development process," he added.

FDA said it may need up to 60 days to take the actions needed to put the program into effect. The agency will not accept requests for inclusion in STeP while it is setting up the program. FDA will share a more detailed look at the program at a Feb. 1 webinar.

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